Role of Tofacitinib in Vitiligo Patients

• Status: Not yet recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Standard treatment for vitiligo often has unsatisfactory outcomes. With a new understanding of pathogenesis, novel drugs have been introduced which have shown to be effective in small-scale studies. Tofacitinib, a Janus kinase(JAK) inhibitor-2 has shown promising results in the treatment of vitiligo. However, randomized controlled studies are required to confirm these observations and identify the patients most likely to benefit from JAK-2 inhibition. This open-labeled randomized clinical trial will be conducted at the department of dermatology and venereology of US Bangla Medical College & Hospital in Dhaka for 6 months duration from June 2021 to November 2021 to Vitiligo patients attending in the aforementioned department will be approached for inclusion in the study. Finally, 80 patients who will fulfill the inclusion and exclusion criteria will be included. All patients will be informed about the nature of the study and the written consent will be taken in the consent form with the assurance that their information will be made confidential. Baseline information such as gender, age, disease history, and drugs used prior will be collected. All patients will undergo baseline laboratory evaluation which will be repeated at 6weeks and 12weeks. Before the beginning of treatment, digital images of the cutaneous lesions will be taken which will be compared with the ones taken at 6weeks and the end of 12weeks follow up. The participants will undergo randomization into 1:1 ratio into two equal groups. Group A will receive oral Tofacitinib and Group B will receive topical 0.1%Mometasone furoate. All the participants will receive allotted intervention for 12weeks. The patient will be followed up at 6 weeks and end of 12 weeks. The primary outcome of the study will be the improvement of the Vitiligo Area Scoring Index (VASI) score at 6 and12 weeks in all groups. Secondary outcomes will include improvement in Vitiligo European Task Force (VETF) scoring. The data will be systematically described and summarized and presented through descriptive statistics and finally will be analyzed by the statistical program Statistical Package for Social Science (SPSS) version 23.0(Chicago, Illinois, USA). The relevant statistical test will be used during the analysis. In all cases, the significance level will set p <0.05. Ethical clearance of the study will be obtained from the ethical review committee (ERC) of the study place.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pi Research Consultancy Center, Bangladesh
• Treatments: Mometasone Furoate; Tofacitinib

Criteria

Inclusion Criteria:

• Age ≥18 years

• Vitiligo patients

• Willing to participate

Exclusion Criteria:

• Age <18 years

• Patients with leukoderma secondary to other causes

• Participants with segmental or universal vitiligo

• Rapidly spreading vitiligo

• Lesions on areas known to be recalcitrant to therapy such as mucosal vitiligo

• Participants with a history of skin cancer

• Radiotherapy use

• Photosensitivity

• Women who are pregnant, breastfeeding or likely to become pregnant during the 9-month treatment period;

• Those currently using immunosuppressive drugs

• Involved in another clinical trial

• Not willing to participate